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Infant, Premature, DiseasesFunkFlowNCT05237622

Functional Residual Capacity During Different Levels of High-flow in Preterm Infants

A study testing High Flow in people with Infant, Premature, Diseases and Respiratory Distress Syndrome, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Although there is a widespread use of HighFlow therapy around the world, there is still uncertainty about the most appropriate initial HighFlow level after nasal continuous positive airway pressure therapy. Read more about this study

Who is it for?
Ages 73 hours and older
What is being tested?
High Flow
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSwitzerland
Study dates
19 Feb 2022to 13 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 73 hours and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Written Informed Consent by one or both parents or legal guardians as documented by signature
  • 30 - 35 weeks postmenstrual age
  • Respiratory support with nCPAP PEEP 5mbar and FiO2 < 0.30
  • > 72 hours old

Who cannot join

  • Inability of the parents to understand the study concept or procedures due to cognitive or linguistic reasons
  • Congenital malformations adversely affecting lung aeration or pulmonary perfusion (e.g. congenital heart or lung defects)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Newborn Research, Department of Neonatology, University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: The FUNK-FLOW Study - Functional Residual Capacity During Different Levels of High-flow in Preterm Infants

Although there is a widespread use of HighFlow therapy around the world, there is still uncertainty about the most appropriate initial HighFlow level after nasal continuous positive airway pressure therapy. Higher levels might produce excessive and harmful intra-alveolar pressures exceeding those reached during nasal continuous positive airway pressure therapy. Low levels may not generate sufficient distending pressures, which may result in a loss of functional residual capacity and an increased risk of respiratory failure. Therefore, the aim of this study is to assess the effect of different HighFlow levels on the functional residual capacity and to compare these findings to the functional residual capacity during nasal continuous positive airway pressure therapy.

Being tested
High Flow
Keywords
Non-invasive respiratory support, HighFlow, continuous positive airway pressure, functional residual capacity
Medical subject headings
Infant, Premature, Diseases, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High FlowDevice

    Standard HighFlow therapy after weaning from continuous positive airway pressure therapy will be applied on different flow levels. Starting with a flow level of 8l/min, the flow-rates will be changed every 30 minutes subsequently from 8-6-4-2-4-6-8 l/min. Meanwhile, data on lung volume changes will be measured using electrical impedance tomography.

Study groups in NCT05237622
Study groupRoleWhat they receive
High FlowOtherStandard HighFlow therapy after weaning from continuous positive airway pressure therapy will be applied on different flow levels. Starting with a flow level of 8l/min, the flow-rates will be changed every 30 minutes subsequently from 8-6-4-2-4-6-8 l/min. Meanwhile, data lung volume changes will be measured using electrical impedance tomography.
Receives: Device: High Flow

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in global end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Change in global EELI over time using electrical impedance tomography (EIT)

    Measured: 230-minute recording period per patient, 30 minutes on each HF level

Secondary outcomes (11)

  1. Change in mean respiratory rate (RR) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Change in RR over time using electrical impedance tomography (EIT)

    Measured: 230-minute recording period per patient, 30 minutes on each HF level

  2. Change in regional end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Change in regional EELI over time using electrical impedance tomography (EIT)

    Measured: 230-minute recording period per patient, 30 minutes on each HF level

  3. Change in mean minute volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Change in mean minute volume over time using electrical impedance tomography (EIT), (AU/kg/min)

    Measured: 230-minute recording period per patient, 30 minutes on each HF level

  4. Change in mean ventilation distribution during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Change in mean ventilation distribution over time using electrical impedance tomography (EIT), (%, left/right and ventral/dorsal)

    Measured: 230-minute recording period per patient, 30 minutes on each HF level

  5. Change in mean silent spaces during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Change in mean silent spaces over time using electrical impedance tomography (EIT), (%, dependent, non-dependent lung)

    Measured: 230-minute recording period per patient, 30 minutes on each HF level

  6. Change in mean tidal volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Change in mean tidal volume over time using electrical impedance tomography (EIT), (AU/kg)

    Measured: 230-minute recording period per patient, 30 minutes on each HF level

  7. Change in number of apnoea that required stimulation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Change in number of apnoea over time

    Measured: 230-minute recording period per patient, 30 minutes on each HF level

  8. Change in heart rate during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Change in heart rate over time

    Measured: 230-minute recording period per patient, 30 minutes on each HF level

  9. Change in oxygen saturation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Change in oxygen saturation over time, SpO2, %

    Measured: 230-minute recording period per patient, 30 minutes on each HF level

  10. Change in fraction of inspired oxygen during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Change in fraction of inspired oxygen over time

    Measured: 230-minute recording period per patient, 30 minutes on each HF level

  11. Change in reaching 'failure criteria' to stop HighFlow therapy during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Definition of failure criteria:

    • Respiratory rate > 100/min for at least 30 minutes during the intervention
    • Increase in FiO2 by ≥ 0.25 from baseline to maintain oxygen saturation level within physician-ordered parameters
    • > 2 apnoea requiring stimulation per 30-minute-intervention

    Measured: 230-minute recording period per patient, 30 minutes on each HF level

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start19 Feb 2022
  3. Primary completion13 Jan 2023
  4. Study completion13 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05237622
Sponsor's protocol ID
FunkFlow
Acronym
FunkFlow
Status last verified
Jul 2024
First submitted
2 Feb 2022
Last updated
9 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Collins CL, Holberton JR, Barfield C, Davis PG. A randomized controlled trial to compare heated humidified high-flow nasal cannulae with nasal continuous positive airway pressure postextubation in premature infants. J Pediatr. 2013 May;162(5):949-54.e1. doi: 10.1016/j.jpeds.2012.11.016. Epub 2012 Dec 20.

    PubMed 23260098

  • Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.

    PubMed 27596161

  • van der Burg PS, Miedema M, de Jongh FH, Frerichs I, van Kaam AH. Cross-sectional changes in lung volume measured by electrical impedance tomography are representative for the whole lung in ventilated preterm infants. Crit Care Med. 2014 Jun;42(6):1524-30. doi: 10.1097/CCM.0000000000000230.

    PubMed 24561568

  • Buchler VL, Gaertner VD, Thomann J, Bassler D, Ruegger CM. Lung Volume Changes in Stable Preterm Infants Weaned From Nasal CPAP to High Flow: A Prospective Cohort Study. CHEST Pulm. 2024 Aug 14;2(4):100094. doi: 10.1016/j.chpulm.2024.100094. eCollection 2024 Dec.

    PubMed 42548445

Questions about this trial

What is this clinical trial studying?

A study testing High Flow in people with Infant, Premature, Diseases and Respiratory Distress Syndrome, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in global end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) (time frame: 230-minute recording period per patient, 30 minutes on each HF level). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05237622, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.

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